Associate Director Clinical Compliance & Processes

Novartis

Dublin, Ireland
**
Clinical development quality standards
Health authority regulations
Gcp sme
** Novartis is seeking an Associate Director of Clinical Compliance & Processes to oversee clinical development quality standards and compliance with health authority regulations in a hybrid working environment. The ideal candidate will have extensive experience in life sciences, specifically within clinical trial leadership, and a strong understanding of Good Clinical Practice and quality management systems. **

Job Summary

  • Ensures Clinical Development operates according to Novartis quality standards and in line with Health Authority regulations.
  • Guides Clinical Development Process SMEs in the development and implementation of cross-functional processes and oversees training compliance.
  • Represents CD at the Global Process and Governance Board and assists in overseeing CAPA, QI, and continuous assessment of quality and compliance risks.

Matching Summary

Match Score: 75

** Novartis is seeking an Associate Director of Clinical Compliance & Processes to oversee clinical development quality standards and compliance with health authority regulations in a hybrid working environment. The ideal candidate will have extensive experience in life sciences, specifically within clinical trial leadership, and a strong understanding of Good Clinical Practice and quality management systems. **

Skills & Requirements

Must-have

  • Clinical Development Quality Standards
  • Health Authority Regulations
  • GCP SME
  • GxP Training Oversight
  • Risk-Based Quality Management

Nice-to-have

  • Curious, inspired, unbossed culture
  • Role model of collaboration
  • Change agent
  • Foster creativity and innovation

Key Requirements

  • Advanced degree in life sciences/healthcare
  • 5+ years experience in life sciences/healthcare/pharma
  • Clinical trial leadership experience a plus
  • Thorough knowledge of GCP, regulations, QMS

Work Rights

Not specified

Tailored Resume

Cover Letter